Small Intestinal Bacterial Overgrowth (SIBO)
Conditions
Keywords
Small Intestinal Bacterial Overgrowth (SIBO), gut health, microbiome, skin, dermatology, botanical medicine
Brief summary
The purpose of this study is to assess how an oral botanical blend alters the gut microbiome and the skin biophysical properties in people with SIBO.
Detailed description
Certain oral botanical blends have many antimicrobial properties. This study will evaluate if a botanical blend can improve the gut and skin health of people with small intestinal bacterial overgrowth (SIBO) since it is caused by an overgrowth of bacteria in the small intestine.
Interventions
DIETARY_SUPPLEMENTLiquid Tincture
Biocidin Liquid Tincture: 1 drop by mouth twice daily, increased by one drop each day until 15 drops twice daily have been reached. 15 drops by mouth twice daily will be maintained through the duration of the study.
DIETARY_SUPPLEMENTGI Detox
GI Detox: 2 capsules by mouth every evening and 1 hour away from all food maintained through the duration of the study.
DIETARY_SUPPLEMENTOlivirex
Olivirex: 2 capsules by mouth twice daily taken with Biocidin liquid tincture starting at week 10 until week 14 of the study for non-responders determined by symptoms and lactulose breath test results.
Sponsors
Biocidin
Integrative Skin Science and Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-Label Prospective Study
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects between 18-60 years of age * Must be willing to comply with all protocol requirements * Must be willing to have flash photo facial images taken with the imaging systems * Males must be willing to shave any facial hair * Subjects with (Small Intestine Bacterial Overgrowth) SIBO
Exclusion criteria
* Any systemic or antibiotics (injected or oral) within 6 months of starting the study. * Any topical antibiotic or benzoyl peroxide within 2 months of starting the study or any subject unwilling to refrain from washout of topical antibacterial or benzoyl peroxide ingredient. * Any other topical products within 2 weeks of starting the study. * Any oral probiotics or prebiotics within 3 months of starting the study. * Any other oral supplements within 3 months of starting the study. * Subjects must have no history of malignancy or cancer or diagnosis of gastrointestinal inflammatory diseases, no history or diagnosis of epilepsy, no history or diagnosis of immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS, lupus, rheumatoid arthritis, irritable bowel disease, multiple sclerosis, Parkinson's disease) * Has a condition or is on medication the investigator and/or designee believe could jeopardize the safety of the subject, interfere with the evaluation, or confound the interpretation of the study results * Has a condition where evening medication dosing is required * Has any gastrointestinal motility condition * Women who have been pregnant in the last three months, are pregnant, preparing to be pregnant or lactating, or post-menopausal. * Is participating in a concurrent clinical research study or has participated in an acne or other facial study at this or any other facility in the past 4 weeks. * Those with BMI higher than 35 kg/m². * Commencement of a new diet (such as the ketogenic diet) or supplements within the 1 month prior to initiating participation, at the discretion of the investigator. * Use of medications that alter blood lipids, such as statins and anti- hyperlipidemic medications. * Is participating in or has participated in a facial study at this or any other facility in the past 4 weeks. Participation in survey-based studies is approved at the discretion of the investigator. * Has a skin disease on face that will interfere with image collection and assessment in the opinion of the investigator. * Refusal to shave or remove facial hair that may interfere with image collection and assessment. * Persons unwilling to avoid the following during the 4 weeks prior and during the duration of the study: self-tanning, spa tanning, sun tanning, or artificial tanning. * Known allergy or irritation to the facial products utilized in the study. * Current tobacco smokers, OR those that have smoked tobacco over the past year, OR a 5 year-pack year history of smoking tobacco. * Prisoners * Any persons with current or a history of alcohol abuse * Adults unable to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lactulose Breath Test | 10 weeks | Presence of SIBO |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gut Microbiome Changes | 10 weeks | Alpha diversity |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Assessment for GI Distress | 10 weeks | Survey based assessment |
| Facial Assessment for Redness | 10 weeks | Via high resolution photography |
Countries
United States
Outcome results
None listed